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Recruiting
NCT07718828
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Conditions: Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Sofia Med Hospital
Location: UMHAT Sofiamed Sofia Sofia-Grad
Summary
This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease. Participants will be randomly assigned to one of two surgical groups. The study will evaluate postoperative pain, health-related quality of life, hospital stay, recurrence of reflux symptoms, gas-bloat symptoms, operative time, fundoplication time, and postoperative complications.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 18 to 90 years
* Patients diagnosed with primary hiatal hernia by fibrogastroscopy and/or barium swallow examination
* Patients with symptoms of gastroesophageal reflux disease
* Patients scheduled for elective laparoscopic hiatal hernia repair with fundoplication
* Patients able to provide informed consent
Exclusion Criteria:
Patients younger than 18 years or older than 90 years Patients with recurrent hiatal hernia Patients who are not suitable for general anesthesia Patients who prefer a surgical approach other than laparoscopic surgery Patients who are unable or unwilling to provide informed consent
Source: ClinicalTrials.gov (NCT07718828). StuddyBuddy aggregates publicly available trial information.